🔍 RecallPedia

Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.

Class I - Dangerous
💊 Drugs Recalled: August 4, 2022 LNK International Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    P121512, exp. date 08/2023; P122015, exp. date 09/2023; P122712, exp. date 11/2023; P123090, exp. date 12/2023; P123170, exp. date 12/2023; P124325, exp. date 03/2024; P124664, exp. date 03/2024; P125165, exp. date 05/2024; P125576, exp. date 06/2024; P125577, exp. date 06/2024; P127089, exp. date 10/2024; P127090, exp. date 10/2024; P127386, exp. date 11/2024; P128572, exp. date 01/2025; P128383, exp. date 01/2025; P129536, exp. date 04/2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
LNK International, Inc.
Reason for Recall:
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.

Product Codes/Lot Numbers:

P121512, exp. date 08/2023; P122015, exp. date 09/2023; P122712, exp. date 11/2023; P123090, exp. date 12/2023; P123170, exp. date 12/2023; P124325, exp. date 03/2024; P124664, exp. date 03/2024; P125165, exp. date 05/2024; P125576, exp. date 06/2024; P125577, exp. date 06/2024; P127089, exp. date 10/2024; P127090, exp. date 10/2024; P127386, exp. date 11/2024; P128572, exp. date 01/2025; P128383, exp. date 01/2025; P129536, exp. date 04/2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1472-2022

Related Recalls

Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81

LNK International

Class I - Dangerous

CGMP Deviations: Released product should have been rejected.

Nov 14, 2024 Over-the-Counter Nationwide View Details →